Funding Anulex Technologies, Inc. secured a $7.0 million growth capital term loan from Silicon Valley Bank. The company plans to use the proceeds to further their R&D efforts, complete their clinical study and expand their sales force. Anulex markets the... more
M&A BoneSupport acquired Ultrazonix, the developer of an ultrasound-based treatment for alleviating pain associated with herniated discs. The product is FDA-cleared and CE-marked. Financial terms were not disclosed. Funding Formae received an investment of $0.5 million from BioAdvance, the Biotechnology... more
Researchers have long suspected that the signaling protein beta-catenin plays a role in how osteoarthritis breaks down cartilage, but until now there has been no definitive research linking the protein to OA. A study from the University of Rochester Medical... more
Last week, the New England Journal of Medicine published a study that more or less said "no". In cautionary scientific parlance, the study concluded that "arthroscopic surgery for osteoarthritis of the knee provides no additional benefit to optimized physical and... more
M&A Wright Medical Group, Inc. acquired the RAYHACK System for wrist reconstruction, which consists of "procedure-specific bone-cutting guides and fixation plates that allow precise shortening and repositioning of the radius and ulna." The system will be available in the U.S.... more
Stryker's bold move a few weeks ago of suing the DOJ over an ongoing investigation has been the subject of wide speculation, and while little is known for sure about what prompted their action, last year's settlement offers some insight.... more
Data from about 160,000 U.K. patients who received hip or knee replacements between 2003 and 2006 show an overall revision rate of one in 75, or 1.4%. Overall, this rate is low, but it was affected by the type of... more
This month, the Journal of Hand Surgery features a report on the two American patients who received allogenic hand and forearm transplants and are performing beyond expectations at 9 and 7 years post-operatively, respectively. Their progress helps demonstrate that transplanting... more
A new study published in JBJS evaluated results from one arm of the SPORT trial to see if herniation level affected discectomy outcomes. The authors undertook the study after a recent randomized trial conducted by Dr. Heikki Osterman et al... more
Researchers at Boston's Joslin Diabetes Center have identified what could be a surprising new way to treat obesity - BMP-7, the bone growth protein familiar to the orthopedic sector as the active protein in Stryker's OP-1, may also support weight... more
Earnings Kensey Nash reported FQ4:08 revenues of $22.0, representing a 29% increase over FQ4:07 and beating estimates by $1.0 million. Biomaterials were up 37% to $13.3 million, which was attributed to strong growth in the orthopedic and cardiovascular product lines.... more
Earnings BioMimetic Therapeutics reported a 2Q:08 net loss of $9.2 million, or $0.50 per diluted share, widening from a net loss of $6.4 million, or $0.35 per diluted share, in 2Q:07. Clinical highlights for the quarter include the announcement of... more
Hip resurfacing devices have only become available in the U.S. in the last two years (Smith & Nephew introduced the BHR in 2006 and Stryker began distributing Corin's Cormet in 2007), and with the relatively recent launch comes an "incomplete"... more
Earnings Alphatec Spine, Inc. reported consolidated revenues for 2Q:08 of $23.9 million, an increase of 27% from the $18.8 million reported in 2Q:07. U.S. revenues for 2Q:08 were $19.4 million, an increase of 20% from the $16.2 million reported in... more
Orthopedics Today is reporting that following the DOJ investigation, research institutions are seeing a slowdown in industry funding (with one unnamed Big-Five company withdrawing "nearly all" of its funding) that could decline even further in 2009. This reduction in funding... more
A recent joint study out of MIT's Picower Institute for Learning and Memory and the Karolinska Institute in Sweden may pave the way for the development of revolutionary, non-surgical treatments for spinal cord injuries. Headed by Konstantinos Meletis, a postdoctoral... more
Earnings Anika Therapeutics reported 2Q:08 revenue of $8.38 million, representing a 32% increase over 2Q:07 but missing estimates by $0.4 million. The company attributed sales growth to the strength of the Orthovisc line. Net income for 2Q:08 was $0.81 million,... more
A study published in the July 14, 2008 issue of Archives of Internal Medicine contends that hip and knee arthroplasty surgeries may be more beneficial to elderly patients than once believed. The study reports that surgery is not only more... more
On Tuesday, we attended the FDA's Orthopaedic & Rehabilitative Devices Panel, Oxiplex/SP was voted "Not Approvable" by a 5-2 vote, based largely on the sponsoring company's inability to definitively demonstrate product effectiveness. The two dissenters would have voted it "Approvable... more
Researchers at the Mississippi Sports Medicine and Orthopaedic Center have found a failure rate nearing 24% for ACL reconstruction in young, athletic patients, according to a new study. Of 61 patients aged 15-39 who underwent ACL reconstruction, 14 were deemed... more
A new JBJS study comparing ReGen Biologics' collagen meniscus implant, Menaflex, with partial meniscectomy was published this week, and the publication comes as a rare bit of good news for the struggling ReGen. At 311 patients, the multi-center study was... more
Regulatory Interventional Spine announced that the FDA has conditionally approved its IDE application for the PercuDyn System, pending the company providing some additional information to the FDA. CEO Walter Cuevas commented that the company will now begin collecting data to... more
Earnings Symmetry Medical reported 1Q:08 revenue of $101.9 million, up 57% from the year-ago period. Revenue was positively affected by the recent acquisitions of TNCO, Inc., Specialty Surgical Instrumentation Inc. and DePuy Orthopaedics, Inc.'s Massachusetts manufacturing facility. Net income for... more
China was a hot topic at the In3 Medical Device Summit, but one event focused on the device industry more broadly: where devices have been and where they're heading. The presentation, led by David Cassak of Windhover Information, described the... more
Results from the Finnish Twin Spine Study show that disc degeneration may not be the result of physical strain, but genetically determined. The study, which was initiated in 1991, examined 147 pairs of identical and 153 pairs of fraternal male... more
Earnings Integra LifeSciences reported its financial results for the first quarter ending March 31, 2008. Total revenues were approximately $156.0 million, reflecting an increase of $33.0 million, or 27%, over the first quarter of 2007. Adjusted net income for the... more
M&A Kinetic Concepts, Inc. announced that it completed its acquisition of LifeCell Corporation. At the time of the expiration of the tender offer, 31.1 million shares of LifeCell common stock had been tendered representing approximately 90.75% of the outstanding shares... more
The double-blinded study is the gold standard of clinical research, but designing surgical trials to those standards can be difficult and often evokes such questionable options as sham surgery. However, one analysis of orthopedic surgical trials found that blinding may... more
Earnings aap Implantate AG announced 1Q:08 revenues of EUR 8.0 million ($12.64 million), up 36% over the year-ago period. The company attributed the growth to a 146% increase in sales in its Trauma & Orthopaedics division, which contributed EUR 3.7... more
Just over a year ago, TiGenix published 12 and 18-month results from their ChondroCelect clinical trial that showed advantages to the ACI treatment when compared to microfracture. Now the company has released further data showing that three years following treatment,... more
M&A Kinetic Concepts, Inc. announced plans to acquire LifeCell for $1.7 billion, or $51.00 per share, which represents an 18% premium over LifeCell's closing price on Friday and a 26% premium over the 90-day volume weighted average trading price. KCI... more
BioMimetic Therapeutics' shares dove sharply last week (and recovered somewhat less sharply) because the FDA raised the possibility that the active ingredient of all of the company's products, PDGF (Platelet-Derived Growth Factor), caused cancer. From Thursday's intraday high price per... more
In the past decade, the use of intramedullary nails in the treatment of hip fractures has increased substantially, despite a lack of evidence supporting the benefits of their use. Additionally, use of the nails varies by geography, differing more than... more
Earnings DJO Inc., formerly ReAble Therapeutics, reported 4Q:07 net sales of $170.7 million, a 97% increase over 4Q:06; the growth rate was due primarily to acquisitions, including ReAble's merger with DJO. The company reported an actual net loss of $57.3... more
Ever wonder how bears can hibernate without suffering from the softened, weakened bones that affect humans following periods of inactivity? Neither did we, until the Wall Street Journal (subscription required) brought it to our attention. The question occurred to nature-lover... more
According to a new study reported on by the New York Times, patient gender appears to influence whether physicians recommend they have a knee replaced. In a Canadian study, a male patient was told twice as often to have the... more
Consumer spending for spinal treatments rose 65% from 1997 to 2005, faster than overall health spending, with patients spending $86 billion to treat back and neck problems. These treatments included drugs, outpatient procedures, ER visits and surgery. However, back pain... more
Earnings ArthroCare reported 4Q:07 revenues of $87.5 million, beating estimates by $1.7 million, representing a 25% increase over the year-ago period. Net income was $14.5 million, or $0.50 per diluted share, missing estimates by a penny and representing a 78%... more
Data from the eagerly-anticipated final arm of the SPORT trial was released today. Results showed that patients receiving decompressive laminectomy for the treatment of spinal stenosis showed improved outcomes following the procedure. Prior arms of the $21 million SPORT trial... more
Earnings Hanger Orthopedic Group reported 4Q:07 net sales of $170.8 million, beating estimates by $7.5 million and representing an 11% over the year-ago period. Revenue growth was attributed to an increase in same-center sales from Hanger's patient care business, an... more
Earnings Smith & Nephew announced 4Q:07 revenues of $967.0 million, beating estimates of $933.0 million and reflecting a 25% (reported) increase over 4Q:06. Adjusted earnings per share was $0.16, in line in estimates and up 10% over the year-ago period.... more
Earnings Kensey Nash reported FQ2:08 total revenues of $19.6 million, missing estimates by $0.05 million and up 14% over the year-ago period. Net sales of biomaterials products increased 15% to $11.5 million, which the company attributed to orthopedic sales. The... more
In the January 30th issue of the New York Times, healthcare reporter Reed Abelson takes a critical look at spine surgery, and in particular a novel device called Prodisc in an article titled "Financial Ties Are Cited as Issue in... more
According to a new study, researchers at McGill University discovered the mechanism by which the protein osteocrin controls bone growth. Mice studies into osteocrin were conducted at Phenogene and Enobia Pharma as well as in Dr. Pierre Moffatt's lab at... more
M&A ArthroCare Corp. acquired DiscoCare, Inc., whom the company describes as "a third-party billing and reimbursement service provider," for $25 million in cash plus potential future milestone payments. The company says, "This acquisition will allow ArthroCare to significantly expand its... more
Testing a common belief that revision total hip arthroplasty is associated with a high complication rate in the very elderly, researchers at Philadelphia's Rothman Institute for Orthopedics retrospectively evaluated outcomes in over 300 THA patents. There were two groups of... more
Regulatory Amedica received FDA clearance for their Valeo™ Pedicle Screw system, a low profile and modular pedicle screw system intended for non-cervical pedicle fixation from the T1 through L5. Corin announced FDA clearance for additional sizes of its Cormet hip... more
Earnings DJO reported 3Q:07 net revenues of $119.8 million, up 5.8% over 3Q:06. Excluding a 2006 revenue benefit from shipping terms and clearing of product backorders associated with Aircast, 3Q:07 revenue was up 7.6% to $121.8 million, in line with... more
Earnings ArthroCare Corp. reported 3Q:07 total revenues of $78.5 million, an increase of 21% over the comparable quarter. Revenues missed estimates by $0.11 million. The company reported net income of $11.1 million, or $0.39 per share, up 28% over 3Q:06... more
Earnings Biomet reported FQ1:08 sales of $552.3 million, up 9% over the comparable quarter. The company reported a net loss for the quarter of $42.9 million, down from an income of $104.4 million for FQ1:07. The company attributed the loss... more
JBJS published results from a prospective, randomized Norweigan trial where 80 patients were selected to receive either autologous chrondocyte implantation (ACI) or microfracture for the treatment of chronic cartilage defects. There were 40 patients in each group. - Five-year follow-up... more
M&A Orthofix acquired the rights to all of the intellectual property related to the InSWing™ interspinous process spacer. InSWing is designed to relieve pain associated with lumbar spinal stenosis and can be used in a minimally invasive surgical procedure. Orthofix... more
Earnings AOI Medical reported a 1H:07 loss of $1.8 million, increasing from a loss of $0.97 million in the comparable half. The company attributed the loss to increased expenses. They expect their product, the Balloon Assisted Management of Spine Fractures,... more
As published in the Lancet this week, results of a new trial showed that a pill called dabigatran etexilate (DE) was as effective as the injected drug enoxaparin in reducing the risk of blood clots following total hip replacement. DE... more
The July U.K. edition of JBJS reported results of a study evaluating the impact of the U.K.'s National Institute for Health and Clinical Excellence (NICE) guidelines for hip replacements. NICE publishes guidelines to promote "good health and the prevention and... more
Regulatory Inion Oy received FDA approval for its implant material BioRestore in dental and cranio-maxillofacial applications. The product is designed to fill bony voids or gaps in the skeleton. BioRestore is currently being reviewed by the FDA for use in... more
Despite randomized clinical trials' status as the most scientifically rigorous of potential research designs, RCTs make up a relatively small percentage of published orthopedics research. More randomized trials are being conducted now than in the past, but ongoing concerns about... more
In the past few years, specialty hospitals have been the subject of controversy, criticized for accepting only the most profitable patients with the lowest risk of complications and for their lack of emergency and charity care. However, a retrospective study... more
Earnings Stryker reported revenues of $1.46 billion, beating estimates of $1.44 billion and increasing 16% from $1.26 billion in 2Q:06. 2Q:07 earnings were $269.1 million, or $0.65 per share, beating estimates of $0.61 and up from $0.52 in the comparable... more
M&A DJO announced on Monday plans for merger with ReAble (formerly Encore Medical). ReAble will acquire all outstanding shares of DJO stock, a transaction valued at approximately $1.6 billion and including the assumption of debt. The transaction will be funded... more
At the AOFAS meeting last week, BioMimetic Therapeutics reported further positive interim data from its ongoing clinical trials of GEM OS1 in foot and ankle fusion indications. The U.S. arm of the study is a randomized, prospective, controlled pilot study... more
On Monday, CMS released a brief Decision Memo on changes to the agency's Clinical Trials Policy. The proposed decision was first announced in April and followed by a public comment period. The memo notes two important changes. One, the final... more
Regulatory Life Spine announced 510(k) clearance for its static anterior cervical plating system Neo®-SL. The system features an integrated lock that allows bone screws to be securely fixated without any additional locking components. The FDA approved new labeling for Genzyme's... more
M&A The private equity consortium set to acquire Biomet increased its buyout offer to $46.00 per share in cash, or an equity value of $11.4 billion. The new offer represents a 32.3% premium over the April 2006 common stock closing... more
Regulatory CMS released a proposed non-coverage decision for lumbar artificial disc replacements following a review of Synthes' Pro-Disc-L. The agency found that LADR is not reasonable and necessary for Medicare recipients over 60 based on lack of relevant data and... more
Spinal fusion is evaluated in the second of three SPORT studies, and patients who selected the surgery to treat degenerative spondylolisthesis had better outcomes when compared with nonsurgical treatment. However, when the results were analyzed on an intention-to-treat basis, there... more
In what may be the first study to evaluate peer-review bias in orthopedics based on submitted, rather than published, studies, Joseph Lynch et al consider associations between scientific and nonscientific variables and outcome as well as acceptance for publication. Lynch... more
Earnings Biologics Integra LifeSciences announced 1Q:07 revenues of $123.0 million, beating estimates of $119.25 million and reflecting a 60% increase over 1Q:06. Net income for the quarter was $9.07 million, or $0.33 per share, meeting analysts' estimates. President and CEO... more
Earnings Spine Kyphon reported that worldwide revenues in 1Q:07 increased 40% to $128.1 million, which includes $18.1 million in X-STOP® Interspinous Process Decompression (IPD®) sales from the St. Francis acquisition. In the U.S., revenues increased 34% to $101.1 million, while... more
Earnings Large Joints Zimmer reported income of $233.4 million, or $0.98 per share, beating estimates of $0.93. The quarter compares to a profit of $205.6 million, or $0.82 per share in 1Q:06. Revenue rose 10% to $950.2 million from $860.4... more
Plans for more rigorous post-marketing policy are underway at the FDA with a new website that tracks post-approval device studies. The website names the manufacturer, device, study description and study status. There is no specific info on clinical studies because... more
Earnings BioMimetic Therapeutics announced 4Q:06 financial results, reporting a net loss of $5.3 million or $0.34 per share and beating analysts' estimates of a loss of $0.37 per share. This compares to a net loss of $9.2 million, or $5.82... more
Earnings Inion announced year-end results for 2006 on Wednesday, reporting a 25% decline in revenues. 2006 sales totaled EUR 5.7 million, compared with EUR 7.6 million in 2005. R&D spending increased 17% to EUR 5.6 million from EUR 4.8 million... more
More than 40% of investigators presenting data at the 2001 and 2002 Annual Meetings of AAOS reported conflicts of interest, and a new study in this month's JBJS shows that those conflicts were associated with positive study findings. Though investigators... more
Following a handful of scandals, donated human tissue has shouldered a reputation for being unsafe and unreliable. However, new data demonstrates one company's efforts to process sterile and high-performance allografts. At a sports medicine conference last fall, Dr. Fred Cushner... more
Earnings Medtronic reported 3Q:07 (ended 1/26/07) Spinal and Navigation revenue of US $629.0 million, and the Spinal segment increased 12% over 3Q:06. Growth was attributed to the Biologics product line and the CD HORIZON® LEGACY™ family of products, which includes... more
Yesterday, TiGenix, a Belgium-based biomedical company, announced the results of their phase III multi-center randomized trial of ChondroCelect as first-line treatment for symptomatic knee cartilage defects. ChondroCelect is designed to be used in combination with autologous chondrocyte implantation (ACI) surgery... more
Earnings Tutogen announced results for first fiscal quarter ending December 31, 2006. Total revenues increased 43% to $11.5 million, compared to $8.0 million in the comparable quarter of fiscal year 2006. U.S. revenues increased 50%, and international revenues increased 27%... more
Earnings Biologics Regeneration Technologies, Inc. reported 4Q:06 revenues of $19.1 million, down 5% from $20.1 million in 4Q:05. The Company reported net loss of $6.7 million, compared to a net lossn of $1.7 million for 4Q:05. Net loss per diluted... more
Orthovita announced this morning that they would apply for 510(k) approval for their Cortoss® Bone Augmentation Material, scrapping a bid for PMA approval. Cortoss is not available in the U.S., but the product has a CE mark in Europe. Applied... more
Earnings Stryker reported a 28% increase in sales of orthopedic implants and endoscopy products for 4Q:06. The Company earned $227.9 million, or 55 cents per share, meeting analysts' estimates, compared with a profit of $178.4 million, or 43 cents per... more
Earnings Lifecore Biomedical reported earnings for the second quarter ending December 31, 2006. Net income fell to $1.37 million, or $.10 per diluted share during the quarter from $1.39 or $.10 per diluted share, in the quarter ending December 31,... more
M&A Paragon Medical has entered into an agreement to acquire OMC Precision Products and Tutela Medicus. OMC provides machining, finishing and assembly of implants, primarily for the spinal and neurological markets, and Tutela offers product development services to device manufacturers... more
We attended last Wednesday's MCAC panel in Baltimore, convened to discuss revisions to CMS' clinical research policy. The panel recommended changes to the terminology and scope of CMS coverage; voting questions covered the definition of a good clinical study, changes... more
Regulatory CryoLife received FDA 510(k) clearance for its ProPatch™ Soft Tissue Repair Matrix, an announcement that drove its stock up 9%. Among other applications, ProPatch can be used to reinforce tissues repaired by sutures or by suture anchors during tendon... more
Earnings ORTHOsoft reported 3Q:06 revenues of CAN $3.8 million (US $3.3 million), up 59% from CAN $2.4 million (US $2.1 million) in 3Q:05. ORTHOsoft manufactures computer aided orthopedic surgery devices, and they attribute the 3Q:06 growth to increased navigation systems... more
In 2005, Nature reported that companies were "queuing up" to conduct clinical trials in China, where a large population simplifies the enrollment process and research could be conducted at lower cost than in the U.S. Similar trends can be seen... more
The first arm of the Spine Patients Outcome Research Trial ("SPORT") study was released by the Journal of the American Medical Association yesterday. The $13.5 million NIH funded SPORT study has been designed to determine the efficacy of spine surgery... more
Earnings: Langer reported their 3Q:06 results on Tuesday, which included a net loss of approximately $553,000, or $.06 per share on a fully diluted basis. Compared to 3Q:05, there was a net income $236,000, or $.02 per share on a... more
In a press release yesterday, Genzyme, maker of Synvisc, announced a CMS decision that would group all viscosupplementation products into the same reimbursement code in January 2007. The company stated that they would fight hard to dispute this decision (through... more
In the wake of demands for increasing clinical volume, decreases in physician income and increasing malpractice costs, it is even more critical to incentivize physicians to perform academic activities that do not directly generate revenue (teaching, research and service) but... more
Earnings Update: CryoLife provided an update on its 3Q:06 projected revenues, which are estimated at ~$20 million, a 22% increase over the comparable quarter of 2005. In 3Q:06, its tissue processing revenues were ~$10.3 million, an increase of 41%, and... more
Asia's continued economic growth makes it an attractive market for both the sale and manufacture of medical devices. Pacific Bridge Medical, a medical consulting firm focusing on business development and regulatory affairs in Asia, recently published an article on the... more
Nanotechonology is clearly making strides in the orthopedic marketplace. The question is, will the FDA will be able to keep up? Report Claims FDA Not "Nano Ready" Yesterday, Michael Tayor, an attorney and former Deputy Commissioner for Policy at the... more
With the 2006 NASS meeting winding down, we thought we'd share some highlights from Seattle. SPORT Clinical Trial Session a Tease On Wednesday, the two-hour, much-anticipated session on SPORT results focused on SPORT background information - but not the data... more
Yesterday's FDA Orthopedic and Rehabilitation Devices advisory panel unanimously recommended approval of Medtronic's PRESTIGE Cervical Disc System. After reviewing the 24 month, ~500 patient multi-center randomized clinical trial data, Wall Street Journal (subscription required) reported that the FDA panel concluded... more
Dr. William Giannobile, a professor of dentistry at the University of Michigan, presented new data on BioMimetics' only approved product, GEM21S, at the American Academy of Periodontology meeting in San Diego yesterday. GEM21S is short for "Growth-factor Enhanced Matrix," a... more
Appointment: Orthovita, Inc. has appointed Albert J. Pavucek, Jr. Vice President Corporate Controller. Mr. Pavucek was with PDI, Inc. serving as Vice President, Finance and Operations. Awards & Recognition: Smith & Nephew plc announced that two of its products, the... more
Appointment: Ranier Technology Limited has appointed John C. Moran to its Board of Directors. Previously, Mr. Moran was a President of Synthes Spine and a Director of Spine Solutions, Inc. Active Implants Corporation (AIC) has hired Richard Treharne, PhD. as... more
You've heard about Botox being used to reduce wrinkles, but did you know it can also be used by orthopedic surgeons? "Botulinum toxin and its orthopaedic applications" was reviewed in this month's British volume of the Journal of Bone and... more
Earnings: Biologics: Orthovita reported 2Q:06 product sales came in at $11.2 million, up 32% compared to 2Q:05. On a non-GAAP basis net loss for the quarter was $5.1 million, or a loss of $0.10 per share. The Company did not... more
Complete Archive
